Senior Regulatory Affairs Specialist

Salary: £46.68 per hour

Medical Device Senior Regulatory Affairs Specialist – Homebased

Opportunity:

This is a great opportunity for a Senior Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for medical devices.

Do you have medical device regulatory affairs experience? Have you got experience in CE marking activities (MDD 93/42/EEC and MDR 2017/745) and UKCA marking activities (UK Medical Device Regulations 2002) for medical devices? Does your experience include BHSA for medical devices? Looking for a long term contract role with an exciting global medical device company? If yes then this is the role for you.

Your role as a Medical Device Senior Regulatory Affairs Specialist based working from home will involve supporting the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) and UKCA marking activities (UK Medical Device Regulations 2002) for medical devices, with emphasis on regulatory compliance and life cycle strategy.

Essential Duties and Responsibilities include:

• Supporting the development/alignment of regulatory policies and strategies across the business. Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices in accordance with the business goals.
• Participating in regional Industry Association Meetings (including MedTech EU working groups).
• Supporting the Legal Manufacturer (BHSA) in its fulfillment of its regulatory responsibilities under the MDD, MDR and UKCA.
• Supporting the maintenance and planning activities related to CE and UKCA marking of BHSA medical devices.
• Supporting BHSA and other company legal manufacturers in CE and UKCA mark related regulatory activities in front of the Notified Bodies, UK Approved Bodies and relevant Competent Authorities.

This is a 12 months contract role which will most likely get extended for another 12 months or potentially go permanent however this is dependent on the individual and the business performance. This is a role based working from home or you can work at the site in Hertfordshire.

The PAYE rate is £46.68.

Skills:

 To apply for role of Medical Device Senior Regulatory Affairs Specialist you will have the following:

• Educated to degree level (a scientific/engineering degree).
• Experience in carrying out the above duties.
• Good medical device regulatory affairs within the EU and UK markets.
• Good knowledge of CE marking of medical devices (MDD 93/42/EEC and related directives and guidelines).

How to Apply:

To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat.

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If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.

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